DRUG DESCRIPTION

Aminosyn® II (an amino acid injection) is a sterile, nonpyrogenic solution
for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk
Package is a sterile dosage form which contains multiple single doses for use
only in a pharmacy bulk admixture program. The formulations are described

Essential Amino Acids (mg/100
mL)

Aminosyn II

10%

15%

Isoleucine

660

990

Leucine

1000

1500

Lysine (acetate)*

1050

1575

Methionine

172

258

Phenylalanine

298

447

Threonine

400

600

Tryptophan

200

300

Valine

500

750

*Amount cited is for lysine alone and does
not include the acetate.

Nonessential Amino Acids (mg/100 mL)

Alanine

993

1490

Arginine

1018

1527

L-Aspartic Acid

700

1050

L-Glutamic Acid

738

1107

Histidine

300

450

Proline

722

1083

Serine

530

795

N-Acetyl-L-Tyrosine

270

405

Glycine

500

750

Other Characteristics

Protein Equivalent (approx. grams/liter)

100

150

Total Nitrogen (grams/liter)

15.3

23.0

Osmolarity (mOsmol/liter, actual)

870

1300

pHa

5.8 (5.0 –6.5)

5.8 (5.0 –6.5)

Specific Gravity

1.03

1.05

Electrolytes (mEq/L)

Sodium (Na+)b

39.8

58.1

Acetate (C2H3O2–)c

71.8

107.6

Sodium Hydrosulfite(mg/100mL)

20

20

a Solution contains sodium hydroxide
for pH adjustment. b Figure includes Na+ from the antioxidant, sodium hydrosulfite
and from the pH adjustor. c Includes acetate from lysine acetate.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not in amounts
to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical
components from the plastic in very small amounts; however, biological testing
was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically significant
changes within the expiration period.

The formulas for the individual amino acids are as follows:

Essential Amino Acids

Isoleucine

CH3CH2CH(CH3)CH(NH2)COOH

Leucine

(CH3)2CHCH2CH(NH2)COOH

Lysine Acetate

H2N(CH2)4CH(NH2)COOH • CH3COOH

Methionine

CH3S(CH2)2CH(NH2)COOH

Phenylalanine

CH2CH(NH2)COOH

Threonine

CH3CH(OH)CH(NH2)COOH

Tryptophan

CH2CH(NH2)COOH

Valine

(CH3)2CHCH(NH2)COOH

Nonessential Amino Acids

Alanine

CH3CH(NH2)COOH

Arginine

H2NC(NH)NH(CH2)3CH(NH2)COOH

L-Aspartic Acid

HOOCCH2CH(NH2)COOH

L-Glutamic Acid

HOOC(CH2)2CH(NH2)COOH

Glycine

H2NCH2COOH

Histidine

CH2CH(NH2)COOH

Proline

Serine

HOCH2CH(NH2)COOH

N-Acetyl-L-Tyrosine

The Pharmacy Bulk Package is designed for use with manual, gravity flow operations
and automated compounding devices for preparing sterile parenteral nutrient
admixtures; it contains no bacteriostat. Multiple single doses may be dispensed
during continual aliquoting operations. Withdrawal of container contents should
be promptly completed within 4 hours after initial closure puncture.

Last reviewed on RxList: 1/14/2009
This monograph has been modified to include the generic and brand name in many instances.